Replacement heart valve commissure assembly

ABSTRACT

A replacement heart valve commissure assembly may include a locking mechanism including a first locking portion spaced apart from a second locking portion in a delivery configuration and configured to engage with the second locking portion in a deployed configuration, wherein the first locking portion is longitudinally actuatable relative to the second locking portion between the delivery and deployed configurations. The commissure assembly may include a first valve leaflet and a second valve leaflet each secured to the first locking portion. A first sleeve portion of the first valve leaflet may be fixedly attached to a first fabric sleeve wrapped around a first leg of the first locking portion by a first filament, and a second sleeve portion of the second valve leaflet may be fixedly attached to a second fabric sleeve wrapped around a second leg of the first locking portion by a second filament.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 toU.S. Provisional Application Ser. No. 62/546,194, filed Aug. 16, 2017,the entirety of which is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing and/or using medical devices. More particularly, thepresent disclosure pertains to commissure assemblies for a replacementheart valve implant.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed formedical use, for example, intravascular use. Some of these devicesinclude guidewires, catheters, medical device delivery systems (e.g.,for stents, grafts, replacement valves, etc.), and the like. Thesedevices are manufactured by any one of a variety of differentmanufacturing methods and may be used according to any one of a varietyof methods. Of the known medical devices and methods, each has certainadvantages and disadvantages. There is an ongoing need to providealternative medical devices as well as alternative methods formanufacturing and using medical devices.

SUMMARY

In a first aspect, a replacement heart valve commissure assembly maycomprise a locking mechanism including a first locking portion spacedapart from a second locking portion in a delivery configuration, whereinthe first locking portion may be configured to engage with the secondlocking portion in a deployed configuration, and the first lockingportion may be longitudinally actuatable relative to the second lockingportion between the delivery configuration and the deployedconfiguration; a first valve leaflet secured to the first lockingportion; and a second valve leaflet secured to the first lockingportion. A first sleeve portion of the first valve leaflet may befixedly attached to a first fabric sleeve wrapped around a first leg ofthe first locking portion by a first filament, and a second sleeveportion of the second valve leaflet may be fixedly attached to a secondfabric sleeve wrapped around a second leg of the first locking portionby a second filament.

In addition or alternatively, and in a second aspect, the first leg ofthe first locking portion and the second leg of the first lockingportion define a longitudinally-oriented tissue slot extending throughfirst locking portion.

In addition or alternatively, and in a third aspect, the first sleeveportion of the first valve leaflet and the second sleeve portion of thesecond valve leaflet both pass through the tissue slot of the firstlocking portion.

In addition or alternatively, and in a fourth aspect, the first sleeveportion of the first valve leaflet may be fixedly attached to the firstfabric sleeve with one or more stitches of the first filament orientedgenerally parallel to the first leg of the first locking portion.

In addition or alternatively, and in a fifth aspect, the second sleeveportion of the second valve leaflet may be fixedly attached to thesecond fabric sleeve with one or more stitches of the second filamentoriented generally parallel to the second leg of the first lockingportion.

In addition or alternatively, and in a sixth aspect, the first lockingportion includes a transverse distal portion extending between a distalend of the first leg and a distal end of the second leg.

In addition or alternatively, and in a seventh aspect, the transversedistal portion of the first locking portion includes an apertureextending through the transverse distal portion of the first lockingportion.

In addition or alternatively, and in an eighth aspect, the firstfilament includes a first distal section passing through the apertureextending through the transverse distal portion of the first lockingportion, and the second filament includes a second distal sectionpassing through the aperture extending through the transverse distalportion of the first locking portion.

In addition or alternatively, and in a ninth aspect, the first filamentincludes a first proximal section wrapped around the first leg proximalof the first fabric sleeve, and the second filament includes a secondproximal section wrapped around the second leg proximal of the secondfabric sleeve.

In addition or alternatively, and in a tenth aspect, at least a portionof the first proximal section of the first filament may be positionedwithin a first lateral recess formed within the first leg proximal ofthe first fabric sleeve, and at least a portion of the second proximalsection of the second filament may be positioned within a second lateralrecess formed within the second leg proximal of the second fabricsleeve.

In addition or alternatively, and in an eleventh aspect, a replacementheart valve implant may comprise an expandable anchor member actuatablebetween a delivery configuration and a deployed configuration; and areplacement heart valve commissure assembly comprising: a lockingmechanism including a first locking portion spaced apart from a secondlocking portion in a delivery configuration, wherein the first lockingportion is configured to engage with the second locking portion in adeployed configuration, and the first locking portion is longitudinallyactuatable relative to the second locking portion between the deliveryconfiguration and the deployed configuration; a first valve leafletsecured to the first locking portion; and a second valve leaflet securedto the first locking portion. A first sleeve portion of the first valveleaflet may be fixedly attached to a first fabric sleeve wrapped arounda first leg of the first locking portion by a first filament, and asecond sleeve portion of the second valve leaflet may be fixedlyattached to a second fabric sleeve wrapped around a second leg of thefirst locking portion by a second filament. The locking mechanism may beconfigured to lock the expandable anchor member in the deployedconfiguration.

In addition or alternatively, and in a twelfth aspect, the replacementheart valve implant may further comprise a polymeric seal memberdisposed on an outer surface of the expandable anchor member andattached to a distal end of the expandable anchor member.

In addition or alternatively, and in a thirteenth aspect, the firstfilament does not pass through the first leg of the first lockingportion, and the second filament does not pass through the second leg ofthe first locking portion.

In addition or alternatively, and in a fourteenth aspect, the firstfabric sleeve and the second fabric sleeve are each formed from a wovenmaterial.

In addition or alternatively, and in a fifteenth aspect, the firstfabric sleeve and the second fabric sleeve are each formed from apolymeric material.

In addition or alternatively, and in a sixteenth aspect, a method ofassembling a replacement heart valve commissure assembly for use in areplacement heart valve implant may comprise the steps of:

inserting a first sleeve portion of a first valve leaflet and a secondsleeve portion of a second valve leaflet through alongitudinally-oriented tissue slot of a first locking portion of alocking mechanism, the locking mechanism comprising the first lockingportion and a second locking portion, wherein the first locking portionis longitudinally actuatable relative to the second locking portion toselectively engage the first locking portion with the second lockingportion;

inserting a first fabric sleeve through the longitudinally-orientedtissue slot between the first sleeve portion of the first valve leafletand a first leg of the first locking portion, and inserting a secondfabric sleeve through the longitudinally-oriented tissue slot betweenthe second sleeve portion of the second valve leaflet and a second legof the first locking portion;

wrapping the first fabric sleeve around the first leg of the firstlocking portion such that the first fabric sleeve overlaps itselfadjacent the first sleeve portion of the first valve leaflet to form afirst overlapped portion, and wrapping the second fabric sleeve aroundthe second leg of the first locking portion such that the second fabricsleeve overlaps itself adjacent the second sleeve portion of the secondvalve leaflet to form a second overlapped portion; and

fixedly attaching the first overlapped portion of the first fabricsleeve to the first sleeve portion of the first valve leaflet, andfixedly attaching the second overlapped portion of the second fabricsleeve to the second sleeve portion of the second valve leaflet.

In addition or alternatively, and in a seventeenth aspect, the methodmay further comprise, prior to wrapping:

aligning a profile of the first sleeve portion of the first valveleaflet with a profile of the first fabric sleeve, and aligning aprofile of the second sleeve portion of the second valve leaflet with aprofile of the second fabric sleeve.

In addition or alternatively, and in an eighteenth aspect, the methodmay further comprise, prior to fixedly attaching:

clamping the first overlapped portion of the first fabric sleeve to thefirst sleeve portion of the first valve leaflet, and clamping the secondoverlapped portion of the second fabric sleeve to the second sleeveportion of the second valve leaflet.

In addition or alternatively, and in a nineteenth aspect, the firstoverlapped portion of the first fabric sleeve may be fixedly attached tothe first sleeve portion of the first valve leaflet using a linearjoining pattern, and the second overlapped portion of the second fabricsleeve may be fixedly attached to the second sleeve portion of thesecond valve leaflet using a linear joining pattern.

In addition or alternatively, and in a twentieth aspect, the firstfabric sleeve, the first sleeve portion of the first valve leaflet, thesecond sleeve portion of the second valve leaflet, and the second fabricsleeve may be disposed in compression between the first leg of the firstlocking portion and the second leg of the first locking portion.

The above summary of some embodiments, aspects, and/or examples is notintended to describe each embodiment or every implementation of thepresent disclosure. The figures and the detailed description whichfollows more particularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 illustrates an example medical device system;

FIG. 2 is a perspective view of an example replacement heart valveimplant in a deployed configuration;

FIG. 3 illustrates an example post member;

FIG. 4 illustrates an example buckle member;

FIG. 5 illustrates selected components of an example replacement heartvalve implant associated with an example medical device system in adelivery configuration;

FIG. 6 illustrates selected components of an example replacement heartvalve implant associated with an example medical device system in areleased configuration;

FIG. 7 illustrates an example valve leaflet;

FIG. 8 is a front perspective view illustrating selected components of areplacement heart valve commissure assembly;

FIG. 8A is a section view of the selected components of FIG. 8 takenalong the line 8A-8A.

FIG. 9 a rear perspective view illustrating the selected components ofthe replacement heart valve commissure assembly of FIG. 8;

FIGS. 10-14 illustrate aspects of a method of assembling selectedcomponents of the replacement heart valve commissure assembly of FIG. 8;and

FIG. 15 is a top view of selected components of the example replacementheart valve implant of FIG. 2.

While aspects of the disclosure are amenable to various modificationsand alternative forms, specifics thereof have been shown by way ofexample in the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit aspects of thedisclosure to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit theclaimed invention. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the claimed invention.

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(e.g., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (e.g., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g., 1 to 5 includes 1,1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges, and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the disclosedinvention are necessarily shown in each figure or discussed in detailbelow. However, it will be understood that the following discussion mayapply equally to any and/or all of the components for which there aremore than one, unless explicitly stated to the contrary. Additionally,not all instances of some elements or features may be shown in eachfigure for clarity.

Relative terms such as “proximal”, “distal”, “advance”, “retract”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “retract” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan. Other relative terms, such as “upstream”, “downstream”,“inflow”, and “outflow” refer to a direction of fluid flow within alumen, such as a body lumen, a blood vessel, or within a device. Stillother relative terms, such as “axial”, “circumferential”,“longitudinal”, “lateral”, “radial”, etc. and/or variants thereofgenerally refer to direction and/or orientation relative to a centrallongitudinal axis of the disclosed structure or device.

The term “extent” may be understood to mean a greatest measurement of astated or identified dimension. For example, “outer extent” may beunderstood to mean a maximum outer dimension, “radial extent” may beunderstood to mean a maximum radial dimension, “longitudinal extent” maybe understood to mean a maximum longitudinal dimension, etc. Eachinstance of an “extent” may be different (e.g., axial, longitudinal,lateral, radial, circumferential, etc.) and will be apparent to theskilled person from the context of the individual usage. Generally, an“extent” may be considered a greatest possible dimension measuredaccording to the intended usage. In some instances, an “extent” maygenerally be measured orthogonally within a plane and/or cross-section,but may be, as will be apparent from the particular context, measureddifferently—such as, but not limited to, angularly, radially,circumferentially (e.g., along an arc), etc.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect the particular feature, structure, orcharacteristic in connection with other embodiments, whether or notexplicitly described, unless clearly stated to the contrary. That is,the various individual elements described below, even if not explicitlyshown in a particular combination, are nevertheless contemplated asbeing combinable or arrangeable with each other to form other additionalembodiments or to complement and/or enrich the described embodiment(s),as would be understood by one of ordinary skill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features. It is to be understood that thenumerical nomenclature is not intended to be limiting and is exemplaryonly. In some embodiments, alterations of and deviations frompreviously-used numerical nomenclature may be made in the interest ofbrevity and clarity. That is, a feature identified as a “first” elementmay later be referred to as a “second” element, a “third” element, etc.or may be omitted entirely, and/or a different feature may be referredto as the “first” element. The meaning and/or designation in eachinstance will be apparent to the skilled practitioner.

Diseases and/or medical conditions that impact the cardiovascular systemare prevalent throughout the world. Traditionally, treatment of thecardiovascular system was often conducted by directly accessing theimpacted part of the system. For example, treatment of a blockage in oneor more of the coronary arteries was traditionally treated usingcoronary artery bypass surgery. As can be readily appreciated, suchtherapies are rather invasive to the patient and require significantrecovery times and/or treatments. More recently, less invasive therapieshave been developed, for example, where a blocked coronary artery couldbe accessed and treated via a percutaneous catheter (e.g., angioplasty).Such therapies have gained wide acceptance among patients andclinicians.

Some relatively common medical conditions may include or be the resultof inefficiency, ineffectiveness, or complete failure of one or more ofthe valves within the heart. For example, failure of the aortic valve orthe mitral valve can have a serious effect on a human and could lead toserious health condition and/or death if not dealt with properly.Treatment of defective heart valves poses other challenges in that thetreatment often requires the repair or outright replacement of thedefective valve. Such therapies may be highly invasive to the patient.Disclosed herein are medical devices that may be used for delivering amedical device to a portion of the cardiovascular system in order todiagnose, treat, and/or repair the system. At least some of the medicaldevices disclosed herein may be used to deliver and implant areplacement heart valve (e.g., a replacement aortic valve, replacementmitral valve, etc.). In addition, the devices disclosed herein maydeliver the replacement heart valve percutaneously and, thus, may bemuch less invasive to the patient. The devices disclosed herein may alsoprovide other desirable features and/or benefits as described below.

The figures illustrate selected components and/or arrangements of amedical device system 10, shown schematically in FIG. 1 for example. Itshould be noted that in any given figure, some features of the medicaldevice system 10 may not be shown, or may be shown schematically, forsimplicity. Additional details regarding some of the components of themedical device system 10 may be illustrated in other figures in greaterdetail. A medical device system 10 may be used to deliver and/or deploya variety of medical devices and/or implants to one or more locationswithin the anatomy. In at least some embodiments, the medical devicesystem 10 may include a replacement heart valve delivery system (e.g., areplacement aortic valve delivery system) that can be used forpercutaneous delivery of a replacement heart valve implant 16 (e.g. areplacement mitral valve, a replacement aortic valve, etc.) to an areaof interest in the anatomy, such as a native heart valve. This, however,is not intended to be limiting as the medical device system 10 may alsobe used for other interventions including valve repair, valvuloplasty,and the like, or other similar interventions.

FIG. 1 illustrates the medical device system 10 including thereplacement heart valve implant 16 configured to be disposed within thearea of interest, such as a native heart valve (e.g., a mitral valve, anaortic valve, etc.), wherein the replacement heart valve implant 16 maybe disposed within a lumen of the medical device system 10 in a deliveryconfiguration for delivery to the area of interest, where thereplacement heart valve implant 16 may be shifted to a deployedconfiguration. In some embodiments, the medical device system 10 mayinclude an outer sheath 12 having a lumen extending from a proximalportion and/or proximal end of the outer sheath 12 to a distal end ofthe outer sheath 12. The replacement heart valve implant 16 may bedisposed within the lumen of the outer sheath 12 proximate the distalend of the outer sheath 12 in the delivery configuration. In someembodiments, the medical device system 10 may include a handle 18disposed proximate and/or at the proximal end of the outer sheath 12.

The medical device system 10 may include an inner sheath or catheter 14disposed within the lumen of the outer sheath 12 and/or slidable withrespect to the outer sheath 12 within the lumen of the outer sheath 12.In some embodiments, the handle 18 may be disposed proximate and/or at aproximal end of the inner sheath or catheter 14. In some embodiments,the inner sheath or catheter 14 may be a tubular structure having one ormore lumens extending therethrough, the inner sheath or catheter 14 maybe a solid shaft, or the inner sheath or catheter 14 may be acombination thereof. In some embodiments, the medical device system 10may include an actuator element 15 releasably connecting the replacementheart valve implant 16 to the handle 18. For example, the actuatorelement 15 may extend from the handle 18 to the replacement heart valveimplant 16, the replacement heart valve implant 16 being disposed at adistal end of the lumen of the outer sheath 12. The actuator element 15may extend distally from the inner sheath or catheter 14 to thereplacement heart valve implant 16. In some embodiments, the actuatorelement 15 may be slidably disposed within and/or may extend slidablythrough the inner sheath or catheter 14.

The handle 18 and/or the actuator element 15 may be configured tomanipulate the position of the outer sheath 12 relative to the innersheath or catheter 14 and/or aid in the deployment of the replacementheart valve implant 16. For example, the inner sheath or catheter 14and/or the actuator element 15 may be used to move the replacement heartvalve implant 16 with respect to the outer sheath 12 of the medicaldevice system 10. In some embodiments, the inner sheath or catheter 14and/or the actuator element 15 may be advanced distally within the lumenof the outer sheath 12 to push the replacement heart valve implant 16out the distal end of the outer sheath 12 and/or the medical devicesystem 10 to deploy the replacement heart valve implant 16 within thearea of interest (e.g., the native heart valve, etc.). Alternatively,the inner sheath or catheter 14 and/or the actuator element 15 may beheld in a fixed position relative to the replacement heart valve implant16 and the outer sheath 12 may be withdrawn proximally relative to theinner sheath or catheter 14, the actuator element 15, and/or thereplacement heart valve implant 16 to deploy the replacement heart valveimplant 16 within the area of interest (e.g., the native heart valve,etc.). Some examples of suitable but non-limiting materials for themedical device system 10, the outer sheath 12, the inner sheath orcatheter 14, the actuator element 15, the handle 18, and/or componentsor elements thereof, are described below.

In some embodiments, the medical device system 10 may include a nosecone disposed at a distal end of a guidewire extension tube, wherein theguidewire extension tube may extend distally from the inner sheath orcatheter 14 and/or the outer sheath 12. In at least some embodiments,the nose cone may be designed to have an atraumatic shape and/or mayinclude a ridge or ledge that is configured to abut a distal end of theouter sheath 12 during delivery of the replacement heart valve implant16.

In use, the medical device system 10 may be advanced percutaneouslythrough the vasculature to the area of interest. For example, themedical device system 10 may be advanced through the vasculature andacross the aortic arch to a defective heart valve (e.g., aortic valve,mitral valve, etc.). Alternative approaches to treat a defective heartvalve are also contemplated with the medical device system 10. Duringdelivery, the replacement heart valve implant 16 may be generallydisposed in an elongated and low profile “delivery” configuration withinthe lumen of the outer sheath 12. Once positioned, the outer sheath 12may be retracted relative to the replacement heart valve implant 16 toexpose the replacement heart valve implant 16. In at least someembodiments, the replacement heart valve implant 16 may be disposed inan “everted” configuration or a partially-everted configuration whiledisposed within the lumen of the outer sheath 12 and/or immediately uponexposure after retracting the outer sheath 12. In some embodiments, thereplacement heart valve implant 16 may be everted in the “delivery”configuration. The “everted” configuration may involve at least aportion of the valve leaflets (discussed below) of the replacement heartvalve implant 16 being disposed outside of the expandable anchor member(discussed below) of the replacement heart valve implant 16 duringdelivery, thereby permitting a smaller radial profile of the replacementheart valve implant 16 and the use of a smaller overall profile of theouter sheath 12 and/or the medical device system 10. In someembodiments, the “delivery” configuration and the “everted”configuration may be substantially similar and/or may be usedinterchangeably herein.

The replacement heart valve implant 16 may be actuated using the handle18 and/or the actuator element 15 in order to translate the replacementheart valve implant 16 into a radially expanded and larger profile“deployed” configuration suitable for implantation within the anatomy atthe area of interest or the target location. When the replacement heartvalve implant 16 is suitably deployed within the anatomy, the outersheath 12 and/or the medical device system 10 can be removed from thevasculature, leaving the replacement heart valve implant 16 in place ina “released” configuration to function as, for example, a suitablereplacement for the native heart valve. In at least some interventions,the replacement heart valve implant 16 may be deployed within the nativeheart valve (e.g., the native heart valve is left in place and notexcised). Alternatively, the native heart valve may be removed and thereplacement heart valve implant 16 may be deployed in its place as areplacement.

Disposed within a first lumen of the inner sheath or catheter 14 may bethe actuator element 15, which may be used to actuate and/or translate(e.g., expand and/or elongate) the replacement heart valve implant 16between the “delivery” configuration and the “deployed” configuration.In some embodiments, the actuator element 15 may include or comprise aplurality of actuator elements 15, two actuator elements 15, threeactuator elements 15, four actuator elements 15, or another suitable ordesired number of actuator elements 15. In some embodiments, eachactuator element 15 may be disposed within a separate lumen of the innersheath or catheter 14. For the purpose of illustration only, the medicaldevice system 10 and the replacement heart valve implant 16 are shownwith three actuator elements 15. In such an example, the three actuatorelements 15 may be disposed within three separate lumens (e.g., a firstlumen, a second lumen, and a third lumen) of the inner sheath orcatheter 14, although such a configuration is not required.

It is to be noted that in order to facilitate understanding, certainfeatures of the disclosure may be described in the singular, even thoughthose features may be plural or recurring within the disclosedembodiment(s). Each instance of the features may include and/or beencompassed by the singular disclosure(s), unless expressly stated tothe contrary. For example, a reference to “the actuator element” may beequally referred to all instances and quantities beyond one of “the atleast one actuator element” or “the plurality of actuator elements”.

FIG. 2 illustrates some selected components of the medical device system10 and/or the replacement heart valve implant 16, shown in the“deployed” configuration. The replacement heart valve implant 16 mayinclude an expandable anchor member 17 that is reversibly actuatablebetween the elongated “delivery” configuration and the radially expandedand/or axially shortened “deployed” configuration. In some embodiments,the expandable anchor member 17 may be tubular and defines a lumenextending coaxially along a central longitudinal axis from a distal orinflow end of the expandable anchor member 17 and/or the replacementheart valve implant 16 to a proximal or outflow end of the expandableanchor member 17 and/or the replacement heart valve implant 16.

In some embodiments, the expandable anchor member 17 may comprise anexpandable stent structure and/or framework. In some embodiments, theexpandable anchor member 17 may comprise a self-expanding braided and/orwoven mesh structure made up of one or more filaments disposed and/orinterwoven circumferentially about the lumen of the expandable anchormember 17 and/or the replacement heart valve implant 16.Non-self-expanding, mechanically-expandable, and/or assistedself-expanding expandable anchor members are also contemplated. In atleast some embodiments, the expandable anchor member 17 may be formed asa unitary structure (e.g., formed from a single filament or strand ofwire, cut from a single tubular member, etc.). In some embodiments, theexpandable anchor member 17 may define a generally cylindrical outersurface in the deployed configuration. Other configurations are alsopossible—a cross-section defining a generally elliptical outer surface,for example. Some examples of suitable but non-limiting materials forthe replacement heart valve implant 16, the expandable anchor member 17,and/or components or elements thereof, are described below.

Also shown in FIG. 2, but omitted from several other figures in theinterest of clarity, the replacement heart valve implant 16 may includea plurality of valve leaflets 22 disposed within the lumen of thereplacement heart valve implant 16 and/or the expandable anchor member17. In some embodiments, the plurality of valve leaflets 22 may beattached and/or secured to the expandable anchor member 17 at aplurality of locations within the lumen of the replacement heart valveimplant 16 and/or the expandable anchor member 17. In some embodiments,the plurality of valve leaflets 22 may be attached and/or secured to theexpandable anchor member 17 using sutures, adhesives, or other suitablemeans.

In some embodiments, the plurality of valve leaflets 22 may include orcomprise two leaflets, three leaflets, four leaflets, etc. as desired.For example, the plurality of valve leaflets 22 may comprise a firstvalve leaflet 24, a second valve leaflet 30, a third valve leaflet 36,etc. (e.g., FIGS. 7 and 15), and may be referred to collectively as theplurality of valve leaflets 22 (e.g., FIG. 2). The plurality of valveleaflets 22 of the replacement heart valve implant 16 may be configuredto move between an open configuration permitting antegrade fluid flowthrough the replacement heart valve implant 16 and/or the lumen of thereplacement heart valve implant 16 and/or the expandable anchor member17, and a closed configuration preventing retrograde fluid flow throughthe replacement heart valve implant 16 and/or the lumen of thereplacement heart valve implant 16 and/or the expandable anchor member17. The plurality of valve leaflets 22 may each have a free edge,wherein the free edges of the plurality of valve leaflets 22 coaptwithin the replacement heart valve implant 16, the expandable anchormember 17, and/or the lumen extending through the replacement heartvalve implant 16 and/or the expandable anchor member 17 in the closedconfiguration. Additional details regarding the plurality of valveleaflets 22 is provided below.

The replacement heart valve implant 16 may include a replacement heartvalve commissure assembly disposed within the lumen of the replacementheart valve implant 16 and/or the expandable anchor member 17. In someembodiments, the replacement heart valve implant 16 may include morethan one replacement heart valve commissure assembly. For example, eachadjacent pair of valve leaflets 22 may form and/or define onereplacement heart valve commissure assembly. Therefore, the number ofreplacement heart valve commissure assemblies may be directly related tothe number of valve leaflets 22 (e.g., three valve leaflets form and/ordefine three replacement heart valve commissure assemblies, two valveleaflets form and/or define two replacement heart valve commissureassemblies, etc.).

In some embodiments, the replacement heart valve implant 16 and/or thereplacement heart valve commissure assembly may include a lockingmechanism 48 configured to lock the expandable anchor member 17 in the“deployed” configuration. In some embodiments, the replacement heartvalve implant 16 may include or comprise a plurality of lockingmechanisms 48, two locking mechanisms 48, three locking mechanisms 48,etc. In some embodiments, each replacement heart valve commissureassembly may correspond to and/or include one corresponding lockingmechanism 48. Each locking mechanism 48 may include a first lockingportion or a post member 60 secured to the expandable anchor member 17and configured to engage with a second locking portion or a bucklemember 50 secured to the expandable anchor member 17, as will bedescribed in more detail below.

In some embodiments, the actuator element 15 may be configured toreleasably engage the locking mechanism 48 and/or reversibly actuate theexpandable anchor member 17 and/or the replacement heart valve implant16 between the “delivery” configuration and the “deployed” configurationand/or the “released” configuration while the actuator element 15 isengaged with the locking mechanism 48. In some embodiments, one actuatorelement 15 may correspond to, engage with, and/or actuate one lockingmechanism 48. In some embodiments, one actuator element 15 maycorrespond to, engage with, and/or actuate more than one lockingmechanism 48. Other configurations are also contemplated.

In some embodiments, the actuator element 15 may include a proximal endand a distal end. In use, the proximal end may be operatively connectedto the handle 18, and/or manipulated or otherwise actuated by a userusing the handle 18, to reversibly shift the replacement heart valveimplant 16 between the “delivery” configuration and the “deployed”configuration. In some embodiments, the actuator element 15 may beaxially translatable relative to the first locking portion or postmember 60 and/or the second locking portion or buckle member 50 of thereplacement heart valve implant 16.

In some embodiments, the actuator element 15 (e.g., each actuatorelement 15, etc.) includes an elongated rod having a flattened distalportion and a ramp extending longitudinally and/or radially outward fromthe actuator element 15 such that the ramp has a greater outer extentthan the elongated rod. The ramp may be positioned proximate to and/orat a proximal end of the flattened distal portion of the actuatorelement 15.

In some embodiments, the flattened distal portion of the actuatorelement 15 may be aligned with and/or releasably coupled to the firstlocking portion or post member 60. In some embodiments, the flatteneddistal portion may be slidably received within a longitudinally-orientedpassageway of the first locking portion or post member 60, as discussedbelow. The handle 18 may be configured to actuate and/or translate theactuator element 15 (e.g., each actuator element 15, etc.) relative tothe outer sheath 12, the replacement heart valve implant 16, thecorresponding locking mechanism(s) 48 (e.g., the plurality of lockingmechanisms 48, etc.), and/or the first locking portion or post member 60in the “delivery” and/or “deployed” configuration.

In some embodiments, the proximal end of the actuator element 15 (eachactuator element 15, etc.) may be operatively connected to a centralshaft extending distally from the handle 18 within the inner sheath orcatheter 14. The central shaft may be actuated and/or translated by thehandle 18 and/or a mechanism disposed within the handle 18. In someembodiments, the actuator element 15 (each actuator element 15, etc.)may extend distally from the handle 18 within the inner sheath orcatheter 14.

In some embodiments, the actuator element 15 and/or the elongated rodmay be generally round, oblong, ovoid, rectangular, polygonal (i.e.,two-sided, three-sided, four-sided, five-sided, six-sided, etc.) and/orcombinations thereof in shape. Other shapes, both regular and irregular,are also contemplated. In some embodiments, the actuator element 15 maybe formed from a single piece of wire, round stock, or other suitablematerial, as discussed herein. In some embodiments, the actuator element15 may be formed by further processing the single piece of wire, roundstock, or other suitable material, such as by machining, stamping, lasercutting, etc. Some suitable but non-limiting materials for the actuatorelement 15, the elongated rod, the flattened distal portion, and/or theramp, for example metallic materials or polymeric materials, aredescribed below.

In some embodiments, the replacement heart valve implant 16 may includea seal member 20 (shown partially cutaway) disposed on and/or around atleast a portion of the outer surface of the expandable anchor member 17.In some embodiments, the seal member 20 may be attached and/or securedto the distal or inflow end of the expandable anchor member 17 and/orthe replacement heart valve implant 16, and/or the seal member 20 may beattached and/or secured to the plurality of valve leaflets 22 proximatethe distal or inflow end of the expandable anchor member 17 and/or thereplacement heart valve implant 16. The seal member 20 may besufficiently flexible and/or pliable to conform to and/or around nativevalve leaflets and/or the native heart valve in the deployedconfiguration, thereby sealing an exterior of the replacement heartvalve implant 16 and/or the expandable anchor member 17 within and/oragainst the native heart valve and/or the native valve leaflets andpreventing leakage around the replacement heart valve implant 16 and/orthe expandable anchor member 17.

In some embodiments, the seal member 20 may include a plurality oflayers of polymeric material. Some suitable polymeric materials mayinclude, but are not necessarily limited to, polycarbonate,polyurethane, polyamide, polyether block amide, polyethylene,polyethylene terephthalate, polypropylene, polyvinylchloride,polytetrafluoroethylene, polysulfone, and copolymers, blends, mixturesor combinations thereof. Other suitable polymeric materials are alsocontemplated, some of which are discussed below.

A pin release assembly 86 may be a linking structure that releasablycouples the first locking portion or post member 60 and the actuatorelement 15. The pin release assembly 86 may include a plurality ofrelease pins 88 that may be joined together via a coiled connection andheld to a pin release mandrel 87, for example with a ferrule, a weld, orother attachment means.

During delivery, the replacement heart valve implant 16 and/or theexpandable anchor member 17 may be secured at the distal end of theinner sheath or catheter 14 by a plurality of fingers 79 of a coupler 78coupled with a projecting portion at a proximal end of the secondlocking portion or buckle member 50 (and being held in place with aslidable collar 80 disposed over the connection) and by the plurality ofrelease pins 88, each release pin 88 securing together the actuatorelement 15 and the first locking portion or post member 60. Theflattened distal portion of the actuator element 15 may include anopening or aperture that can be aligned with an aperture 68 of atransverse distal portion of the first locking portion or post member 60(described in more detail below). When so aligned, the plurality ofrelease pins 88 can be looped through a coupling aperture extendingthrough the first locking portion or post member 60 proximate theelongated proximal portion 62 and the opening or aperture of theactuator element 15. This releasably secures the actuator element 15 tothe first locking portion or post member 60, thereby limiting relativeaxial movement between the actuator element 15 and the first lockingportion or post member 60 and forms a configuration of these structuresthat can be utilized during delivery of the replacement heart valveimplant 16. A guide 82 may be disposed over each of the plurality offingers 79 proximal of the slidable collar 80 and may serve to keep theplurality of fingers 79 of the coupler 78 associated with theirrespective actuator element 15 extending adjacent to (and axiallyslidable relative to) the plurality of fingers 79 of the coupler 78.

After the replacement heart valve implant 16 and/or the expandableanchor member 17 is advanced within the anatomy to the area of interest,the actuator element 15 can be used to actuate the replacement heartvalve implant 16 and/or the expandable anchor member 17 to the“deployed” configuration by proximally retracting the actuator element15 relative to the second locking portion or buckle member 50 and/or theexpandable anchor member 17, thereby pulling the first locking portionor post member 60 into engagement with the second locking portion orbuckle member 50, as discussed below. Finally, the plurality of releasepins 88 can be removed by retracting the pin release mandrel 87 and/orthe pin release assembly 86 using the handle 18, thereby uncoupling theactuator element 15 from the first locking portion or post member 60,which allows the replacement heart valve implant 16 to be released fromthe medical device system 10 in the “released” configuration.

In some embodiments, the first locking portion or post member 60 and thesecond locking portion or buckle member 50 may be longitudinally movablerelative to each other along an inner surface of the expandable anchormember 17 in the “delivery” configuration and/or the “deployed”configuration. In some embodiments, the first locking portion or postmember 60 may be non-releasably secured to a distal portion and/orproximate the distal or upstream end of the expandable anchor member 17along the inner surface of the expandable anchor member 17. In someembodiments, the second locking portion or buckle member 50 may befixedly secured to a proximal portion and/or proximate the proximal ordownstream end of the expandable anchor member 17 against the innersurface of the expandable anchor member 17. The second locking portionor buckle member 50 may be configured to slidably receive at least aportion of the first locking portion or post member 60 therein.Additional discussion regarding the relative motion of these elements isprovided below.

FIG. 3 illustrates an example first locking portion or post member 60.In at least some embodiments, the first locking portion or post member60 may include an elongated proximal portion 62, a first leg 64 fixedlyattached to and extending distally from the elongated proximal portion62, and a second leg 66 fixedly attached to and extending distally fromthe elongated proximal portion 62. The first locking portion or postmember 60 may include a transverse distal portion fixedly attached toand extending laterally and/or circumferentially between a distal end ofthe first leg 64 and a distal end of the second leg 66. In someembodiments, the first locking portion or post member 60 may be formedas a single unitary structure, wherein the elongated proximal portion62, the first leg 64, the second leg 66, and the transverse distalportion are integrally formed with each other and/or from a single pieceof material. In some embodiments, the transverse distal portion of thefirst locking portion or post member 60 may include an aperture 68extending through the transverse distal portion of the first lockingportion or post member 60 in a radial direction relative to the centrallongitudinal axis of the replacement heart valve implant 16 and/or theexpandable anchor member 17.

In some embodiments, the elongated proximal portion 62 of the firstlocking portion or post member 60 may include a longitudinally-orientedpassageway 61 extending at least partially through the elongatedproximal portion 62 of the first locking portion or post member 60,wherein the flattened distal portion of the actuator element 15 isconfigured to slidably engage the longitudinally-oriented passageway 61of the elongated proximal portion 62 of the first locking portion orpost member 60. In some embodiments, the longitudinally-orientedpassageway 61 may extend completely through the elongated proximalportion 62 of the first locking portion or post member 60. In someembodiments, a longitudinal axis of the longitudinally-orientedpassageway 61 and/or the elongated proximal portion 62 of the firstlocking portion or post member 60 may be arranged generally parallel tothe central longitudinal axis of the expandable anchor member 17 and/orthe replacement heart valve implant 16.

The longitudinally-oriented passageway 61 may be configured to slidablyreceive the flattened distal portion of the actuator element 15. Thelongitudinally-oriented passageway 61 may include an internalcross-sectional shape or profile corresponding to an externalcross-sectional shape or profile of the flattened distal portion of theactuator element 15. In some embodiments, the flattened distal portionof the actuator element 15 may be slidably disposed within thelongitudinally-oriented passageway 61 and/or may be releasably coupledto the first locking portion or post member 60 by the release pin 88,for example. In some embodiments, at least a portion of the flatteneddistal portion of the actuator element 15 may extend into thelongitudinally-oriented passageway 61 when the flattened distal portionof the actuator element 15 is engaged with the longitudinally-orientedpassageway 61 of the elongated proximal portion 62 of the first lockingportion or post member 60, for example in the elongated “delivery”configuration and/or the “everted” configuration.

In some embodiments, the first locking portion or post member 60 may bedisposed within the lumen of the replacement heart valve implant 16and/or the expandable anchor member 17 proximate the distal or inflowend of the replacement heart valve implant 16 and/or the expandableanchor member 17 when the expandable anchor member 17 is in theelongated “delivery” configuration and/or the “everted” configuration.In some embodiments, at least a portion of the first locking portion orpost member 60 may be disposed distal of the expandable anchor member 17when the expandable anchor member 17 is in the elongated “delivery”configuration and/or the “everted” configuration.

In some embodiments, the first leg 64 of the first locking portion orpost member 60 and the second leg 66 of the first locking portion orpost member 60 may be laterally and/or circumferentially spaced apartfrom each other to define a longitudinally-oriented tissue slot 67extending through the first locking portion or post member 60 in aradial direction relative to the central longitudinal axis of thereplacement heart valve implant 16 and/or the expandable anchor member17. In some embodiments, a length of the longitudinally-oriented tissueslot 67 may extend and/or may be oriented generally parallel with thecentral longitudinal axis of the expandable anchor member 17 and/or thereplacement heart valve implant 16. The first leg 64 of the firstlocking portion or post member 60 may include a first lateral recess 63formed within the first leg 64 proximate a proximal end of thelongitudinally-oriented tissue slot 67. The first lateral recess 63 maybe formed and/or extend laterally and/or circumferentially into an outersurface of the first leg 64 toward the longitudinally-oriented tissueslot 67. The second leg 66 of the first locking portion or post member60 may include a second lateral recess 65 formed within the second leg66 proximate a proximal end of the longitudinally-oriented tissue slot67. The second lateral recess 65 may be formed and/or extend laterallyand/or circumferentially into an outer surface of the second leg 66toward the longitudinally-oriented tissue slot 67. In at least someembodiments, the first lateral recess 63 and the second lateral recess65 may face in opposite lateral or circumferential directions.

In some embodiments, the elongated proximal portion 62 of the firstlocking portion or post member 60 may include a transversely-orienteddepression and/or ridge proximate a proximal end of the elongatedproximal portion 62. As will be explained further below, thetransversely-oriented depression and/or ridge of the elongated proximalportion 62 may be configured to engage a transversely-oriented ridge ofthe second locking portion or buckle member 50 to lock the replacementheart valve implant 16 and/or the expandable anchor member 17 in the“deployed” configuration.

In some embodiments, the elongated proximal portion 62 of the firstlocking portion or post member 60 may include a keying or orientingshape formed in and/or extending longitudinally along a length and/or anouter surface of the elongated proximal portion 62 of the first lockingportion or post member 60. In some embodiments, the keying or orientingshape may extend along an entire length of the elongated proximalportion 62 of the first locking portion or post member 60. As willbecome apparent, the keying or orienting shape may serve as an alignmentand/or anti-rotation feature with respect to the second locking portionor buckle member 50. For example, the keying or orienting shape mayprevent relative rotation between the first locking portion or postmember 60 and the second locking portion or buckle member 50 when theelongated proximal portion 62 of the first locking portion or postmember 60 is engaged with the second locking portion or buckle member50. Some suitable but non-limiting materials for the first lockingportion or post member 60, for example metallic materials or polymericmaterials, are described below.

FIG. 4 illustrates an example second locking portion or buckle member50. The second locking portion or buckle member 50 may include a baseportion 51 having a longitudinal axis extending between a proximal endand a distal end of the second locking portion or buckle member 50. Thesecond locking portion or buckle member 50 may include a body portion 52fixedly attached to and/or integrally formed with the base portion 51,the body portion 52 defining a longitudinal channel 56 extending throughthe body portion 52 of the second locking portion or buckle member 50.In at least some embodiments, the longitudinal channel 56 may beoriented substantially parallel with the longitudinal axis of the baseportion 51. In some embodiments, at least a part of the body portion 52may extend away from a distal portion of a top surface of the baseportion 51. For example, the body portion 52 may extend radially inwardfrom the base portion 51 relative to the central longitudinal axis ofthe replacement heart valve implant 16 and/or the expandable anchormember 17.

In some embodiments, the body portion 52 of the second locking portionor buckle member 50 may include a flap portion 53 extending proximallyand/or toward the proximal end of the base portion 51 from the bodyportion 52. In some embodiments, the flap portion 53 may include atransversely-oriented ridge 54 extending toward the base portion 51 andlaterally across the base portion 51, such that when the second lockingportion or buckle member 50 is viewed along the longitudinal axis of thebase portion 51, the transversely-oriented ridge 54 obstructs at least aportion of the longitudinal channel 56. In some embodiments, the bodyportion 52 and/or the flap portion 53 of the second locking portion orbuckle member 50 may include at least one hole or aperture formedtherein for attaching a radiopaque marker to the second locking portionor buckle member 50 to aid in visualization of the second lockingportion or buckle member 50.

The flap portion 53 may be configured to deflect radially relative tothe central longitudinal axis of the expandable anchor member 17 and/orthe replacement heart valve implant 16. As will become more evident fromthe discussion below, the ramp of the actuator element 15 may beconfigured to deflect the flap portion 53 of the second locking portionor buckle member 50 radially inward as the ramp (and the first lockingportion or post member 60 engaged thereto) is longitudinally translatedthrough the longitudinal channel 56 of the body portion 52 of the secondlocking portion or buckle member 50. In some embodiments, the flapportion 53 may be biased or self-biased toward a neutral positionaligned with the body portion 52 and/or may be biased or self-biasedinto the longitudinal channel 56 and/or toward the base portion 51 ofthe second locking portion or buckle member 50.

In some embodiments, the second locking portion or buckle member 50 mayinclude a projecting portion 55 at a proximal end of the base portion 51of the second locking portion or buckle member 50, the projectingportion 55 being configured to releasably attach the replacement heartvalve implant 16 to the medical device system 10 and/or the inner sheathor catheter 14. In at least some embodiments, the longitudinal channel56 may have a keyed, directional, or non-round cross-sectional profileor shape configured to slidably receive the first locking portion orpost member 60. The first locking portion or post member 60 may have anexternal cross-sectional profile or shape corresponding to the keyed,directional, or non-round internal cross-sectional profile or shape ofthe longitudinal channel 56. For example, the longitudinal channel 56and/or the projecting portion 55 may include a flat surfacecorresponding to a flat side of the first locking portion or post member60. Other corresponding surfaces and/or profiles are also contemplated.As such, the first locking portion or post member 60 may benon-rotatable relative to the second locking portion or buckle member 50when the elongated proximal portion 62 of the first locking portion orpost member 60 is engaged with and/or at least partially disposed withinthe longitudinal channel 56 of the second locking portion or bucklemember 50 and/or when the flat side of the first locking portion or postmember 60 is aligned with and/or in facing engagement with the flatsurface of the second locking portion or buckle member 50. Some suitablebut non-limiting materials for the second locking portion or bucklemember 50, for example metallic materials or polymeric materials, aredescribed below.

Briefly returning to FIG. 2, in some embodiments, attachment between thereplacement heart valve implant 16 and the inner sheath or catheter 14may be effected through the use of a coupler 78. The coupler 78 maygenerally include a base (not shown) that may be attached to a distalend of the inner sheath or catheter 14. Projecting distally from thebase is a plurality of fingers 79 (e.g., two fingers, three fingers,four fingers, etc.) that are each configured to engage with thereplacement heart valve implant 16 at the projecting portion 55 of thesecond locking portion or buckle member 50 of the locking mechanism 48.In some embodiments, each of the plurality of fingers 79 may extend fromthe base and/or the distal end of the inner sheath or catheter 14 to thereplacement heart valve implant 16. In some embodiments, each finger 79may include a collar 80 slidably disposed about its respective finger 79and the projecting portion 55 of its respective second locking portionor buckle member 50.

During delivery, the replacement heart valve implant 16 may be securedat the distal end of the coupler 78 and/or the inner sheath or catheter14 by two elongated tines of the finger 79 of the coupler 78 beingmatingly coupled with the projecting portion 55 of the second lockingportion or buckle member 50 by the collar 80, and by the actuatorelement 15 being coupled to its corresponding first locking portion orpost member 60, for example by the release pin 88. When the replacementheart valve implant 16 is advanced within the anatomy to the area ofinterest, the outer sheath 12 may be translated and/or actuatedproximally to expose the replacement heart valve implant 16. Then, theactuator element 15 can be actuated (e.g., proximally retracted) toaxially shorten and/or radially expand the replacement heart valveimplant 16 and/or the expandable anchor member 17 from the “delivery”configuration toward the “deployed” configuration by proximallyretracting and/or translating the actuator element 15 to pull the firstlocking portion or post member 60 into engagement with the secondlocking portion or buckle member 50, using the handle 18 for example.After verifying satisfactory placement of the replacement heart valveimplant 16, such as by an appropriate imaging technique, the actuatorelement 15 may each be rotated relative to and decoupled from the firstlocking portion or post member 60, which allows the distal portion ofthe actuator element 15 to be pulled proximally out of the secondlocking portion or buckle member 50, where the ramp subsequently engagesthe collar 80 and thereby retracts the collar 80 from the two elongatedtines and the projecting portion 55. Once the collar 80 has beenretracted, the two elongated tines decouple from the projecting portion55, and the finger 79 of the coupler 78 may be withdrawn from thereplacement heart valve implant 16 thereby leaving the replacement heartvalve implant 16 (and/or the expandable anchor member 17) in the anatomyat the area of interest in a “released” configuration.

FIGS. 5-6 illustrate selected components of the locking mechanism 48configured to reversibly lock the replacement heart valve implant 16(and/or the expandable anchor member 17) in the “deployed” configurationand/or the “released” configuration, and the general operation of thosecomponents. For simplicity and clarity purposes, only one of eachactuator element 15, first locking portion or post member 60, secondlocking portion or buckle member 50, etc. is shown and discussed (thewhole replacement heart valve implant 16 is not shown to facilitateunderstanding of the locking mechanism(s) 48). However, it will beunderstood that the following discussion may apply equally to any and/orall of the components for which there are more than one within thereplacement heart valve implant 16 (i.e., the actuator element 15, thesecond locking portion or buckle member 50, the first locking portion orpost member 60, etc.) and/or the medical device system 10, unlessexplicitly stated to the contrary.

As seen in FIG. 5, each actuator element 15 extends through a guide 82adjacent to and surrounding the finger 79 of the coupler 78, through thecollar 80, through the second locking portion or buckle member 50, andinto engagement with the first locking portion or post member 60. Forexample, the actuator element 15 (e.g., the plurality of actuatorelements 15, etc.) corresponding to each locking mechanism 48 (e.g., theplurality of locking mechanisms 48, etc.) extends longitudinally throughthe second locking portion or buckle member 50 of its respective lockingmechanism 48 in the “delivery” configuration.

The actuator element 15 may be axially and/or slidably translatablethrough and/or relative to the guide 82, the collar 80, and/or thesecond locking portion or buckle member 50. The actuator element 15 maybe slidable within the longitudinally-oriented passageway 61 of thefirst locking portion or post member 60. As discussed above, theflattened distal portion of the actuator element 15 may be configured toslidably engage and/or extend into the longitudinally-orientedpassageway 61 of the first locking portion or post member 60.

The release pin 88 may extend through the coupling aperture extendingthrough the first locking portion or post member 60 proximate theelongated proximal portion 62, and the opening or aperture through theflattened distal portion of the actuator element 15 to releasably couplethe flattened distal portion of the actuator element 15 to the firstlocking portion or post member 60 in the “delivery” configuration. Ascan be appreciated, a proximal end of the first locking portion or postmember 60 and a distal end of the second locking portion or bucklemember 50 may be longitudinally separated and/or spaced apart in the“delivery” configuration (as seen in FIG. 5, for example). In at leastsome embodiments, the first locking portion or post member 60 may belongitudinally actuatable and/or translatable relative to the secondlocking portion or buckle member 50 in the “delivery” configuration,and/or between the “delivery” configuration and the “deployed”configuration.

When the replacement heart valve implant 16 reaches the area of interestwithin the anatomy, a clinician can actuate (e.g., proximally retract)the actuator element 15, for example using the handle 18, thereby movingand/or translating the proximal end of the first locking portion or postmember 60 toward the distal end of the second locking portion or bucklemember 50 and into the longitudinal channel 56 of the second lockingportion or buckle member 50 in order to axially shorten and/or radiallyexpand the expandable anchor member 17 and/or the replacement heartvalve implant 16 towards the “deployed” configuration. Ultimately, theactuator element 15 can be retracted sufficiently far enough totranslate the actuator element 15 past the flap portion 53 of the secondlocking portion or buckle member 50 as the ramp passes through thelongitudinal channel 56 of the second locking portion or buckle member50, thereby permitting the ramp of the actuator element 15 to deflectthe flap portion 53 of the second locking portion or buckle member 50radially inward as the ramp (and the first locking portion or postmember 60 engaged thereto) is longitudinally translated through thelongitudinal channel 56 of the body portion 52 of the second lockingportion or buckle member 50. In at least some embodiments, the firstlocking portion or post member 60 may be longitudinally actuatableand/or translatable relative to the second locking portion or bucklemember 50 between the “delivery” configuration and the “deployed”configuration.

As the first locking portion or post member 60 is actuated and/ortranslated proximally through and/or relative to the second lockingportion or buckle member 50, the transversely-oriented depression and/orridge proximate the proximal end of the elongated proximal portion 62engages the transversely-oriented ridge 54 of the second locking portionor buckle member 50 to lock the expandable anchor member 17 and/or thereplacement heart valve implant 16 into the “deployed” configuration.Engagement of the transversely-oriented depression and/or ridgeproximate the proximal end of the elongated proximal portion 62 and thetransversely-oriented ridge 54 of the second locking portion or bucklemember 50 limit or prevent distal movement and/or axial translation ofthe first locking portion or post member 60 relative to the secondlocking portion or buckle member 50 in the “deployed” configurationafter the actuator element 15 has been disengaged from the lockingmechanism 48 and/or the first locking portion or post member 60.Following locking of the expandable anchor member 17 and/or thereplacement heart valve implant 16 in the “deployed” configuration,positioning of the replacement heart valve implant 16 may be verifiedusing a suitable imaging technique.

In some embodiments and/or some procedures, it may be desirable toremove and/or reposition the replacement heart valve implant 16 and/orexpandable anchor member 17. To do so, a clinician may urge and/ortranslate the actuator element 15 in a second (e.g., distal) directionto extend and/or elongate the expandable anchor member 17 back towardsthe “delivery” configuration. Axial translation of the actuator element15 in the second (e.g., distal) direction relative to the lockingmechanism 48 (e.g., the first locking portion or post member 60 and/orthe second locking portion or buckle member 50) may slidably engage theramp of the actuator element 15 with the flap portion 53 and/or thetransversely-oriented ridge 54 the second locking portion or bucklemember 50, thereby deflecting the flap portion 53 of the second lockingportion or buckle member 50 away from the longitudinal channel 56 of thesecond locking portion or buckle member 50 and/or the actuator element15 and/or radially inward relative to the central longitudinal axis ofthe expandable anchor member 17, and permitting the first lockingportion or post member 60 to pass back through and/or out of thelongitudinal channel 56 of the second locking portion or buckle member50.

Upon verification of proper positioning at the area of interest, therelease pin(s) 88 may be withdrawn from the coupling aperture extendingthrough the first locking portion or post member 60 proximate theelongated proximal portion 62, and the opening or aperture through theflattened distal portion of the actuator element 15. Once the actuatorelement 15 has been disengaged and/or detached from the first lockingportion or post member 60, and the ramp has been axially translated awayfrom the locking mechanism 48 (e.g., the first locking portion or postmember 60 and/or the second locking portion or buckle member 50), andthe replacement heart valve implant 16 and/or the expandable anchormember 17 in the “deployed” configuration, further actuation and/orretraction of the actuator element 15 may cause the ramp of the actuatorelement 15 to engage the collar 80 and pull/slide the collar 80proximally along the finger 79 while further withdrawing the actuatorelement 15 from the first locking portion or post member 60. In doingso, the two elongated tines of the finger 79 may be exposed anddecoupled from the projecting portion 55 of the second locking portionor buckle member 50, as seen in FIG. 6. Withdrawal of the actuatorelement 15 completely from the longitudinally-oriented passageway 61 ofthe first locking portion or post member 60 releases the expandableanchor member 17 and/or the replacement heart valve implant 16 andleaves the replacement heart valve implant 16 disposed at the area ofinterest in the “released” configuration.

FIG. 7 illustrates an example valve leaflet (e.g., a first valve leaflet24, a second valve leaflet 30, a third valve leaflet 36) of theplurality of valve leaflets 22. In some embodiments, the first valveleaflet 24, the second valve leaflet 30, and/or the third valve leaflet36 may each include a body portion 29/35/41 (respectively), a firstsleeve portion 25/31/37 (respectively), a second sleeve portion 26/32/38(respectively) opposite the first sleeve portion 25/31/37 (respectively)relative to the body portion 29/35/41 (respectively), and a free edge27/33/39 (respectively) extending between the first sleeve portion25/31/37 (respectively) and the second sleeve portion 26/32/38(respectively). The free edges 27/33/29 may coapt with each other in theclosed configuration to prevent retrograde fluid flow through thereplacement heart valve implant 16, and may move radially outwardlyrelative to the central longitudinal axis and/or the expandable anchormember 17 in the open configuration to permit antegrade fluid flowthrough the replacement heart valve implant 16.

The first valve leaflet 24, the second valve leaflet 30, and/or thethird valve leaflet 36 may each further include a front surface, a backsurface, and side edges 28/34/40 (respectively). In some embodiments,the front surface may have a different texture than the back surface. Inat least some embodiments, the front surface of the first valve leaflet24, the front surface of the second valve leaflet 30, and the frontsurface of the third valve leaflet 36 may each face radially inwardlytoward the central longitudinal axis. In some embodiments, the firstvalve leaflet 24, the second valve leaflet 30, and/or the third valveleaflet 36 may each define notches along the side edges 28/34/40(respectively) adjacent to the first sleeve portion 25/31/37(respectively) and the second sleeve portion 26/32/38 (respectively).Some examples of suitable but non-limiting materials for the pluralityof valve leaflets 22 (e.g., the first valve leaflet 24, the second valveleaflet 30, the third valve leaflet 36, etc.) may include bovinepericardial, polymeric materials, or other suitably flexiblebiocompatible materials.

FIGS. 8, 8A, and 9 illustrate different views of selected elements ofthe replacement heart valve commissure assembly of the disclosure. Insome embodiments, the replacement heart valve commissure assemblyincludes the first valve leaflet 24 secured to the first locking portionor post member 60 and the second valve leaflet 30 secured to the firstlocking portion or post member 60. As above, the description herein iswritten using these exemplary features, but the numerical identifiers(e.g., first, second, etc.) may be changed as necessary forother/additional instances of this or similar features, as will beapparent to the skilled practitioner.

In some embodiments, the first sleeve portion 25 of the first valveleaflet 24 and the second sleeve portion 32 of the second valve leaflet30 may both pass through the longitudinally-oriented tissue slot 67extending through the first locking portion or post member 60 betweenthe first leg 64 of the first locking portion or post member 60 and thesecond leg 66 of the first locking portion or post member 60. To improveclarity, portions of the first valve leaflet 24 and the second valveleaflet 30 (e.g., the body portion 29/35/41, the side edges 28/34/40,etc.) are not shown. The first sleeve portion 25 of the first valveleaflet 24 may be fixedly attached to a first fabric sleeve 70 wrappedaround the first leg 64 of the first locking portion or post member 60by a first filament 90. The second sleeve portion 32 of the second valveleaflet 30 may be fixedly attached to a second fabric sleeve 72 wrappedaround the second leg 66 of the first locking portion or post member 60by a second filament 94. In some embodiments, the first sleeve portion25 of the first valve leaflet 24 may be fixedly attached to the firstfabric sleeve 70 with one or more stitches of the first filament 90oriented generally parallel to the first leg 64 of the first lockingportion or post member 60. In some embodiments, the second sleeveportion 32 of the second valve leaflet 30 may be fixedly attached to thesecond fabric sleeve 72 with one or more stitches of the second filament94 oriented generally parallel to the second leg 66 of the first lockingportion or post member 60. Other configurations, including quantity offilaments and/or orientation of filaments are also contemplated.Additionally, other joining means (e.g., staples, rivets, adhesives,etc.), and varying quantities thereof, for fixedly attaching the firstsleeve portion 25 to the first fabric sleeve 70 and/or fixedly attachingthe second sleeve portion 32 to the second fabric sleeve 72 are alsocontemplated.

In some embodiments, the first filament 90 includes a first distalsection 91 passing through the aperture 68 extending through thetransverse distal portion of the first locking portion or post member60, and the second filament 94 includes a second distal section 95passing through the aperture 68 extending through the transverse distalportion of the first locking portion or post member 60. In someembodiments, the first filament 90 includes a first proximal section 92wrapped around the first leg 64 of the first locking portion or postmember 60 proximal of the first fabric sleeve 70, and the secondfilament 94 includes a second proximal section 96 wrapped around thesecond leg 66 of the first locking portion or post member 60 proximal ofthe second fabric sleeve 72. In some embodiments, at least a portion ofthe first proximal section 92 of the first filament 90 is positionedwithin the first lateral recess 63 formed within the first leg 64proximal of the first fabric sleeve 70. In some embodiments, at least aportion of the second proximal section 96 of the second filament 94 ispositioned within the second lateral recess 65 formed within the secondleg 66 proximal of the second fabric sleeve 72. In at least someembodiments, the first filament 90 does not pass through the first leg64 of the first locking portion or post member 60. In at least someembodiments, the second filament 94 does not pass through the second leg66 of the first locking portion or post member 60. For example, thefirst leg 64 and/or the second leg 66 of the first locking portion orpost member 60 may lack holes or apertures extending therethrough, thusreducing the processing and/or manufacturing time and cost of the firstlocking portion or post member 60.

In some embodiments, the first fabric sleeve 70, the first sleeveportion 25 of the first valve leaflet 24, the second sleeve portion 32of the second valve leaflet 30, and the second fabric sleeve 72 may bedisposed in compression between the first leg 64 of the first lockingportion or post member 60 and the second leg 66 of the first lockingportion or post member 60. For example, a combined thickness of thefirst fabric sleeve 70, the first sleeve portion 25 of the first valveleaflet 24, the second sleeve portion 32 of the second valve leaflet 30,and the second fabric sleeve 72 may be greater than a width of thelongitudinally-oriented tissue slot 67 defined by the first leg 64 ofthe first locking portion or post member 60 and the second leg 66 of thefirst locking portion or post member 60.

In some embodiments, the first fabric sleeve 70 and/or the second fabricsleeve 72 may each be formed from a woven material. In some embodiments,the first fabric sleeve 70 and/or the second fabric sleeve 72 may eachbe formed from a polymeric material. In some embodiments, the firstfabric sleeve 70 and/or the second fabric sleeve 72 may each be formedfrom a metallic material. In some embodiments, the first fabric sleeve70 and/or the second fabric sleeve 72 may each be formed from othermaterials and/or combinations of materials providing sufficientflexibility, strength, and tear resistance. Some examples of suitablebut non-limiting materials for the first fabric sleeve 70, the secondfabric sleeve 72, the first filament 90, the second filament 94, etc.,for example metallic materials, polymeric materials, and/or wovenmaterials are described below.

FIGS. 10-14 illustrate selected elements in an example method ofassembling of a replacement heart valve commissure assembly for use inthe replacement heart valve implant 16. As shown in FIG. 10, the methodmay include inserting the first sleeve portion 25 of the first valveleaflet 24 and the second sleeve portion 32 of the second valve leaflet30 through the longitudinally-oriented tissue slot 67 of the firstlocking portion or post member 60 of the locking mechanism 48, thelocking mechanism 48 comprising the first locking portion or post member60 and the second locking portion or buckle member 50.

As seen in FIG. 11, the method may include inserting the first fabricsleeve 70 through the longitudinally-oriented tissue slot 67 between thefirst sleeve portion 25 of the first valve leaflet 24 and the first leg64 of the first locking portion or post member 60, and inserting thesecond fabric sleeve 72 through the longitudinally-oriented tissue slot67 between the second sleeve portion 32 of the second valve leaflet 30and the second leg 66 of the first locking portion or post member 60.

In some embodiments, the method may include aligning a profile (e.g., anouter perimeter, an outer edge, etc.) of the first sleeve portion 25 ofthe first valve leaflet 24 with a profile of the first fabric sleeve 70and/or a profile of the first overlapped portion 71 of the first fabricsleeve, and aligning a profile of the second sleeve portion 32 of thesecond valve leaflet 30 with a profile of the second fabric sleeve 72and/or a profile of the second overlapped portion 73 of the secondfabric sleeve 72.

As seen in FIG. 12, the method may include wrapping the first fabricsleeve 70 around the first leg 64 of the first locking portion or postmember 60 such that the first fabric sleeve 70 overlaps itself adjacentthe first sleeve portion 25 of the first valve leaflet 24 to form afirst overlapped portion 71 of the first fabric sleeve 70, and wrappingthe second fabric sleeve 72 around the second leg 66 of the firstlocking portion or post member 60 such that the second fabric sleeve 72overlaps itself adjacent the second sleeve portion 32 of the secondvalve leaflet 30 to form a second overlapped portion 73 of the secondfabric sleeve 72.

As seen in FIG. 13, the method may include clamping the first overlappedportion 71 of the first fabric sleeve 70 to the first sleeve portion 25of the first valve leaflet 24 using a first clamping element 98, andclamping the second overlapped portion 73 of the second fabric sleeve 72to the second sleeve portion 32 of the second valve leaflet 30 using asecond clamping element 99. In some embodiments, the first clampingelement 98 and the second clamping element 99 may be independent and/orseparate structures. In some embodiments, the first clamping element 98and the second clamping element 99 may be joined together, may be joinedto a common fixture, and/or may be a single structure. Otherconfigurations are also contemplated.

As shown in FIG. 14, the method may include fixedly attaching the firstoverlapped portion 71 of the first fabric sleeve 70 to the first sleeveportion 25 of the first valve leaflet 24 using the first filament 90, asdescribed above, and fixedly attaching the second overlapped portion 73of the second fabric sleeve 72 to the second sleeve portion 32 of thesecond valve leaflet 30 using the second filament 94, as describedabove. In some embodiments, the first overlapped portion 71 of the firstfabric sleeve 70 is fixedly attached to the first sleeve portion 25 ofthe first valve leaflet 24 using a linear joining pattern and/orlinearly-aligned stitches of the first filament 90, and the secondoverlapped portion 73 of the second fabric sleeve 72 is fixedly attachedto the second sleeve portion 32 of the second valve leaflet 30 using alinear joining pattern and/or linearly-aligned stitches of the secondfilament 94.

As mentioned above, there may be multiple instances of certainsingularly-described features present in the disclosed device(s) and/orapparatus. Merely as an example to improve understanding of certainfeatures, FIG. 15 illustrates a top view of selected elements of thereplacement heart valve implant 16. As may be seen in FIG. 15, thereplacement heart valve implant 16 may include an expandable anchormember 17, a first locking mechanism including a first locking portionor post member 60, a second locking mechanism including a first lockingportion or post member 60, and a third locking mechanism including afirst locking portion or post member 60. Each locking mechanism and/orfirst locking portion or post member 60 may be identical to the others,or there may be differences between them depending upon the requirementsof the replacement heart valve implant 16. The replacement heart valveimplant 16 may include a first valve leaflet 24 having a first sleeveportion 25 and an opposing second sleeve portion 26, a second valveleaflet 30 having a first sleeve portion 31 and an opposing secondsleeve portion 32, and a third valve leaflet 36 having a first sleeveportion 37 and an opposing second sleeve portion 38.

The first sleeve portion 25 of the first valve leaflet 24 and the secondsleeve portion 32 of the second valve leaflet 30 may pass though thelongitudinally-oriented tissue slot of the first locking portion or postmember 60 of the first locking mechanism, as described above. The firstsleeve portion 31 of the second valve leaflet 30 and the second sleeveportion 38 of the third valve leaflet 36 may pass though thelongitudinally-oriented tissue slot of the first locking portion or postmember 60 of the second locking mechanism. The first sleeve portion 37of the third valve leaflet 36 and the second sleeve portion 26 of thefirst valve leaflet 24 may pass though the longitudinally-orientedtissue slot of the first locking portion or post member 60 of the thirdlocking mechanism.

The materials that can be used for the various components of the medicaldevice system 10, the outer sheath 12, the inner sheath or catheter 14,the replacement heart valve implant 16, the handle 18, etc. (and/orother systems disclosed herein) and the various elements thereofdisclosed herein may include those commonly associated with medicaldevices. For simplicity purposes, the following discussion makesreference to the medical device system 10, the outer sheath 12, theinner sheath or catheter 14, the replacement heart valve implant 16, thehandle 18, etc. However, this is not intended to limit the devices andmethods described herein, as the discussion may be applied to otherelements, members, components, or devices disclosed herein, such as, butnot limited to, the actuator element(s) 15, the seal member 20, theplurality of valve leaflets 22, the expandable anchor member 17, thesecond locking portion or buckle members 50, the first locking portionor post member 60, the first fabric sleeve 70, the second fabric sleeve72, the collars 80, the guides 82, the first filament 90, the secondfilament 94, etc., and/or elements or components thereof.

In some embodiments, the medical device system 10, the outer sheath 12,the inner sheath or catheter 14, the replacement heart valve implant 16,the handle 18, etc., and/or components thereof (such as, but not limitedto, the actuator element(s) 15, the seal member 20, the plurality ofvalve leaflets 22, the expandable anchor member 17, the second lockingportion or buckle members 50, the first locking portion or post member60, the first fabric sleeve 70, the second fabric sleeve 72, the collars80, the guides 82, the first filament 90, the second filament 94, etc.),may be made from a metal, metal alloy, polymer (some examples of whichare disclosed below), a metal-polymer composite, ceramics, combinationsthereof, and the like, or other suitable material. Some examples ofsuitable metals and metal alloys include stainless steel, such as 444V,444L, and 314LV stainless steel; mild steel; nickel-titanium alloy suchas linear-elastic and/or super-elastic nitinol; other nickel alloys suchas nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;platinum; palladium; gold; combinations thereof; and the like; or anyother suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear than the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also be distinguished based on its composition), whichmay accept only about 0.2 to 0.44 percent strain before plasticallydeforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Other suitable materials may include ULTANIUM™(available from Neo-Metrics) and GUM METAL™ (available from Toyota). Insome other embodiments, a superelastic alloy, for example a superelasticnitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the medical devicesystem 10, the outer sheath 12, the inner sheath or catheter 14, thereplacement heart valve implant 16, the handle 18, etc., and/orcomponents thereof, may also be doped with, made of, or otherwiseinclude a radiopaque material. Radiopaque materials are understood to bematerials capable of producing a relatively bright image on afluoroscopy screen or another imaging technique during a medicalprocedure. This relatively bright image aids a user in determining thelocation of the medical device system 10, the outer sheath 12, the innersheath or catheter 14, the replacement heart valve implant 16, thehandle 18, etc. Some examples of radiopaque materials can include, butare not limited to, gold, platinum, palladium, tantalum, tungsten alloy,polymer material loaded with a radiopaque filler, and the like.Additionally, other radiopaque marker bands and/or coils may also beincorporated into the design of the medical device system 10, the outersheath 12, the inner sheath or catheter 14, the replacement heart valveimplant 16, the handle 18, etc. to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the medical device system 10, the outersheath 12, the inner sheath or catheter 14, the replacement heart valveimplant 16, the handle 18, etc. For example, the medical device system10, the outer sheath 12, the inner sheath or catheter 14, thereplacement heart valve implant 16, the handle 18, etc., and/orcomponents or portions thereof, may be made of a material that does notsubstantially distort the image and create substantial artifacts (e.g.,gaps in the image). Certain ferromagnetic materials, for example, maynot be suitable because they may create artifacts in an MRI image. Themedical device system 10, the outer sheath 12, the inner sheath orcatheter 14, the replacement heart valve implant 16, the handle 18,etc., or portions thereof, may also be made from a material that the MRImachine can image. Some materials that exhibit these characteristicsinclude, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g.,UNS: R44003 such as ELGILOY®, PHYNOX®, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such asMP35-N® and the like), nitinol, and the like, and others.

In some embodiments, the medical device system 10, the outer sheath 12,the inner sheath or catheter 14, the replacement heart valve implant 16,the handle 18, etc., and/or portions thereof, may be made from orinclude a polymer or other suitable material. Some examples of suitablepolymers may include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP),polyoxymethylene (POM, for example, DELRIN® available from DuPont),polyether block ester, polyurethane (for example, Polyurethane 85A),polypropylene (PP), polyvinylchloride (PVC), polyether-ester (forexample, ARNITEL® available from DSM Engineering Plastics), ether orester based copolymers (for example, butylene/poly(alkylene ether)phthalate and/or other polyester elastomers such as HYTREL® availablefrom DuPont), polyamide (for example, DURETHAN® available from Bayer orCRISTAMID® available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, polyurethane silicone copolymers (forexample, ElastEon® from Aortech Biomaterials or ChronoSil® fromAdvanSource Biomaterials), biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the sheath can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the medical device system 10, the outer sheath 12,the inner sheath or catheter 14, the replacement heart valve implant 16,the handle 18, the first fabric sleeve 70, the second fabric sleeve 72,etc. and/or other elements disclosed herein may include a fabricmaterial disposed over or within the structure. The fabric material maybe composed of a biocompatible material, such a polymeric material orbiomaterial, adapted to promote tissue ingrowth. In some embodiments,the fabric material may include a bioabsorbable material. Some examplesof suitable fabric materials include, but are not limited to,polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE),a polyolefinic material such as a polyethylene, a polypropylene,polyester, polyurethane, and/or blends or combinations thereof.

In some embodiments, the medical device system 10, the outer sheath 12,the inner sheath or catheter 14, the replacement heart valve implant 16,the handle 18, the first fabric sleeve 70, the second fabric sleeve 72,the first filament 90, the second filament 94, etc. may include and/orbe formed from a textile material. Some examples of suitable textilematerials may include synthetic yarns that may be flat, shaped, twisted,textured, pre-shrunk or un-shrunk. Synthetic biocompatible yarnssuitable for use in the present invention include, but are not limitedto, polyesters, including polyethylene terephthalate (PET) polyesters,polypropylenes, polyethylenes, polyurethanes, polyolefins, polyvinyls,polymethylacetates, polyamides, naphthalene dicarboxylene derivatives,natural silk, and polytetrafluoroethylenes. Moreover, at least one ofthe synthetic yarns may be a metallic yarn or a glass or ceramic yarn orfiber. Useful metallic yarns include those yarns made from or containingstainless steel, platinum, gold, titanium, tantalum or a Ni—Co—Cr-basedalloy. The yarns may further include carbon, glass or ceramic fibers.Desirably, the yarns are made from thermoplastic materials including,but not limited to, polyesters, polypropylenes, polyethylenes,polyurethanes, polynaphthalenes, polytetrafluoroethylenes, and the like.The yarns may be of the multifilament, monofilament, or spun-types. Thetype and denier of the yarn chosen may be selected in a manner whichforms a biocompatible and implantable prosthesis and, more particularly,a vascular structure having desirable properties.

In some embodiments, the medical device system 10, the outer sheath 12,the inner sheath or catheter 14, the replacement heart valve implant 16,the handle 18, etc. may include and/or be treated with a suitabletherapeutic agent. Some examples of suitable therapeutic agents mayinclude anti-thrombogenic agents (such as heparin, heparin derivatives,urokinase, and PPack (dextrophenylalanine proline argininechloromethylketone)); anti-proliferative agents (such as enoxaparin,angiopeptin, monoclonal antibodies capable of blocking smooth musclecell proliferation, hirudin, and acetylsalicylic acid);anti-inflammatory agents (such as dexamethasone, prednisolone,corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine);antineoplastic/antiproliferative/anti-mitotic agents (such aspaclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine,epothilones, endostatin, angiostatin and thymidine kinase inhibitors);anesthetic agents (such as lidocaine, bupivacaine, and ropivacaine);anti-coagulants (such as D-Phe-Pro-Arg chloromethyl keton, an RGDpeptide-containing compound, heparin, anti-thrombin compounds, plateletreceptor antagonists, anti-thrombin antibodies, anti-platelet receptorantibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, andtick antiplatelet peptides); vascular cell growth promoters (such asgrowth factor inhibitors, growth factor receptor antagonists,transcriptional activators, and translational promoters); vascular cellgrowth inhibitors (such as growth factor inhibitors, growth factorreceptor antagonists, transcriptional repressors, translationalrepressors, replication inhibitors, inhibitory antibodies, antibodiesdirected against growth factors, bifunctional molecules consisting of agrowth factor and a cytotoxin, bifunctional molecules consisting of anantibody and a cytotoxin); cholesterol-lowering agents; vasodilatingagents; and agents which interfere with endogenous vascoactivemechanisms.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made to details, particularly in matters ofshape, size, and arrangement of steps, without exceeding the scope ofthe invention. This may include, to the extent that it is appropriate,the use of any of the features of one example embodiment being used inother embodiments. The invention's scope is, of course, defined in thelanguage in which the appended claims are expressed.

What is claimed is:
 1. A replacement heart valve commissure assembly,comprising: a locking mechanism including a first locking portion spacedapart from a second locking portion in a delivery configuration, whereinthe first locking portion is configured to engage with the secondlocking portion in a deployed configuration, and the first lockingportion is longitudinally actuatable relative to the second lockingportion between the delivery configuration and the deployedconfiguration; a first valve leaflet secured to the first lockingportion; and a second valve leaflet secured to the first lockingportion; wherein a first sleeve portion of the first valve leaflet isfixedly attached to a first fabric sleeve wrapped around a first leg ofthe first locking portion by a first filament, and a second sleeveportion of the second valve leaflet is fixedly attached to a secondfabric sleeve wrapped around a second leg of the first locking portionby a second filament.
 2. The replacement heart valve commissure assemblyof claim 1, wherein the first leg of the first locking portion and thesecond leg of the first locking portion define a longitudinally-orientedtissue slot extending through first locking portion.
 3. The replacementheart valve commissure assembly of claim 2, wherein the first sleeveportion of the first valve leaflet and the second sleeve portion of thesecond valve leaflet both pass through the tissue slot of the firstlocking portion.
 4. The replacement heart valve commissure assembly ofclaim 1, wherein the first sleeve portion of the first valve leaflet isfixedly attached to the first fabric sleeve with one or more stitches ofthe first filament oriented generally parallel to the first leg of thefirst locking portion.
 5. The replacement heart valve commissureassembly of claim 1, wherein the second sleeve portion of the secondvalve leaflet is fixedly attached to the second fabric sleeve with oneor more stitches of the second filament oriented generally parallel tothe second leg of the first locking portion.
 6. The replacement heartvalve commissure assembly of claim 1, wherein the first locking portionincludes a transverse distal portion extending between a distal end ofthe first leg and a distal end of the second leg.
 7. The replacementheart valve commissure assembly of claim 6, wherein the transversedistal portion of the first locking portion includes an apertureextending through the transverse distal portion of the first lockingportion.
 8. The replacement heart valve commissure assembly of claim 7,wherein the first filament includes a first distal section passingthrough the aperture extending through the transverse distal portion ofthe first locking portion, and the second filament includes a seconddistal section passing through the aperture extending through thetransverse distal portion of the first locking portion.
 9. Thereplacement heart valve commissure assembly of claim 1, wherein thefirst filament includes a first proximal section wrapped around thefirst leg proximal of the first fabric sleeve, and the second filamentincludes a second proximal section wrapped around the second legproximal of the second fabric sleeve.
 10. The replacement heart valvecommissure assembly of claim 9, wherein at least a portion of the firstproximal section of the first filament is positioned within a firstlateral recess formed within the first leg proximal of the first fabricsleeve, and at least a portion of the second proximal section of thesecond filament is positioned within a second lateral recess formedwithin the second leg proximal of the second fabric sleeve.
 11. Areplacement heart valve implant, comprising: an expandable anchor memberactuatable between a delivery configuration and a deployedconfiguration; and a replacement heart valve commissure assemblycomprising: a locking mechanism including a first locking portion spacedapart from a second locking portion in a delivery configuration, whereinthe first locking portion is configured to engage with the secondlocking portion in a deployed configuration, and the first lockingportion is longitudinally actuatable relative to the second lockingportion between the delivery configuration and the deployedconfiguration; a first valve leaflet secured to the first lockingportion; and a second valve leaflet secured to the first lockingportion; wherein a first sleeve portion of the first valve leaflet isfixedly attached to a first fabric sleeve wrapped around a first leg ofthe first locking portion by a first filament, and a second sleeveportion of the second valve leaflet is fixedly attached to a secondfabric sleeve wrapped around a second leg of the first locking portionby a second filament wherein the locking mechanism is configured to lockthe expandable anchor member in the deployed configuration.
 12. Thereplacement heart valve implant of claim 11, further comprising apolymeric seal member disposed on an outer surface of the expandableanchor member and attached to a distal end of the expandable anchormember.
 13. The replacement heart valve implant of claim 11, wherein thefirst filament does not pass through the first leg of the first lockingportion, and the second filament does not pass through the second leg ofthe first locking portion.
 14. The replacement heart valve implant ofclaim 11, wherein the first fabric sleeve and the second fabric sleeveare each formed from a woven material.
 15. The replacement heart valveimplant of claim 11, wherein the first fabric sleeve and the secondfabric sleeve are each formed from a polymeric material.